FDA device listing
HeRO Graft
FDA device listing 1538164469 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | HeRO Graft |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Premarket submissions | K124039 |
| Product codes | DSY, LJS, MSD |
| Device names | DSY - Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, LJS - Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, MSD - Catheter, Hemodialysis, Implanted |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.3450, 876.5540, 880.5970 |
| Review panels | Cardiovascular, Gastroenterology & Urology, General Hospital |
| Registered establishments | Merit Medical Asia Company Limited, Merit Medical Australia Pty Ltd., Merit Medical Canada Ltd., Merit Medical Nederland BV, MERIT MEDICAL SYSTEMS, INC., Merit Medical UK Limited |
| Establishment registrations | 1721504, 3006950086, 3012536737, 3015225571, 3015309643, 3033589330 |
| FEI numbers | 1721504, 3006950086, 3012536737, 3015225571, 3015309643, 3033589330 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database